Sr Research Associate II, Analytical Ops

Sr Research Associate II, Analytical Ops
United States - California - Foster City

Gilead Sciences, Inc. is a research-based bio-pharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. With each new discovery and investigational drug candidate, we seek to improve the care of patients living with life-threatening diseases around the world. Gilead’s therapeutic areas of focus include HIV/AIDS, liver diseases, cancer and inflammation, and serious respiratory and cardiovascular conditions.

Making an impact on a global scale
Inclusion is one of the company’s five core values. That’s because we know that we are stronger and more innovative at Gilead when we are informed by a diverse set of backgrounds, experiences and points of view. Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide.

When you join Gilead, you join our mission to change the world by enabling people to live healthier and more fulfilling lives. Come join a mission-driven bio-pharmaceutical organization that values inclusion and diversity, has a strong portfolio of products, and is constantly #CreatingPossible

Gilead Sciences is continuing to hire for all open roles. Our interview process may be conducted virtually and some roles will be asked to temporarily work from home. Over the coming weeks and months, we will be implementing a phased approach to bringing employees back to site to ensure the health and safety of our teams.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.

Job Description


Senior Research Associate II, Release and Stability Group in AOS

Essential Duties and Job Functions:

• Independently conduct GMP routine analysis following written procedures using analytical techniques such as appearance, water content, dissolution, disintegration, High Performance Liquid Chromatography, Ultra Performance Liquid Chromatography (UPLC / HPLC), Gas Chromatography (GC), Differential Scanning Calorimetry (DSC), particle size, X-ray Powder Diffraction (XRPD), and UV-Vis spectroscopy, etc.
  
• Apply knowledge of current Good Manufacturing Practices (cGMPs) on a daily basis
  
• Perform verification and data review of routine and non-routine testing (e.g. stability, release, validation, investigational, transfer, etc.) to ensure compliance to appropriate test methods, specifications, and protocols
  
• Independently perform stability data trending and analyzes data for non-routine testing (e.g. validation, investigational, transfer, etc.)
  
• Conducts laboratory investigations and support deviations
  
• Write and revise protocols, methods, Standard Operating Procedures (SOPs), reports, laboratory investigations, deviations, Corrective Action Preventive Action (CAPAs) with limited guidance
  
• Present data within department, assist in generating technical presentations, and interact with other groups within the department
  
• Provide on-the-job training of physical testing and chromatographic techniques to new hires or junior staff
  
• Support compendial review program as needed
  
• Independently plans and executes assigned experiments and projects (e.g. investigations, validation, transfer, etc.)
  
• Independently troubleshoots instrumentation and test methods
  
• Support internal audits and regulatory inspections as needed
  
• May serve as Business Process Lead (BPL) for instrumentation/software related to the laboratory
  
• May shadow stability leads or lead stability and cross-functional projects with guidance
  

Knowledge and Skills:

• Extensive hands-on experience as an Analytical Chemist or Scientist with analytical techniques such as High Performance Liquid Chromatography, Ultra Performance Liquid Chromatography (HPLC/UPLC), Dissolution, Karl Fischer Titration, Gas Chromatography (GC), Differential Scanning Calorimetry, Thermogravimetric Analysis (DSC/TGA), particle size, X-ray Powder Diffraction (XRPD), disintegration, etc.
  
• Have technical and laboratory skills to execute analyses efficiently and reliably in GMP regulated analytical laboratories
  
• Good understanding of industry standards, cGMPs, quality control (QC), and pharmacopeias
  
• Solid knowledge in Lab information system and software (e.g. Electronic Lab Notebook (ELN), Laboratory Information Management System (LIMS), Laboratory Execution System (LES), Empower, LabX, Scientific Data Management System (SDMS), Trackwise (GTrack), Veeva Vault (GVault), etc.)
  
• Efficiently and effectively plan and execute routine and non-routine analysis (e.g. stability, release, validation, investigational, transfer, etc.)
  
• Ability to work independently and as part of a team with self-motivation, adaptability, and a positive attitude
  
• Ability to clearly and concisely present/articulate testing and analysis results to internal and external audiences
  
• Excellent interpersonal skills and ability to work effectively with people from a wide range of skill levels and experience
  
• Excellent verbal and written communication skills
  
• Experience in analytical chemistry testing of Biologics is a plus
  

Education and Experience:

• BS or BA degree in Chemistry, Biology or a related scientific discipline with 4 years or M.S. degree with 2+ years of relevant experience in biotech/pharmaceutical industry
  

For jobs in the United States:

As an equal opportunity employer, Gilead Sciences Inc. is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact careers@gilead.com for assistance.

Following extensive monitoring, research, consideration of business implications and advice from internal and external experts, Gilead has made the decision to require all U.S., Canada, Australia, Singapore, and Hong Kong employees and contractors to receive the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.​

For more information about equal employment opportunity protections, please view the 'EEO is the Law' poster.

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Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team.

Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion.

For Current Gilead Employees and Contractors:

Please log onto your Internal Career Site to apply for this job.






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